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Mesenchymal Stem Cells for Progressive Multiple Sclerosis_Sweden

Primary Purpose

Autologous Mesenchymal Stem Cells, Multiple Sclerosis

Status

Completed

Phase

Phase 1

Locations

Sweden

Study Type

Interventional

Intervention

Autologous mesenchymal stem cells

About this trial

This is an interventional treatment trial for Autologous Mesenchymal Stem Cells focused on measuring Mesenchymal Stem Cells, Multiple Sclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of MS
1. Active relapsing remitting MS (RRMS) as evidenced by presence of ≥ 1 clinically documented relapse in the past 12 months or ≥2 clinically documented relapses in the last 24 months.
2. Secondary progressive MS with clinical progression as evidenced by an increase of 1 EDSS point (or 0,5 p if EDSS ≥ 5 at time for study start) in the last year or evidenced by ≥1 relapse or ≥ GEL at MRI performed within the last year.
3. Primary progressive MS with clinical progression as evidenced by an increase of 1 EDSS point (or 0,5 p if EDSS ≥ 5 at time for study start) in the last year.
Age_ 18-65 years
Disease duration: 2-20 years
EDSS 3,0-7,0

Exclusion Criteria:

Subtype of MS not fulfilling inclusion criteria
Treatment with any immunosuppressive therapy, including natalizumab and fingolimod, within the 3 months prior to randomization
Treatment with interferon-beta or glatiramer acetate within the 30 days prior to randomization
Treatment with corticosteroids within the 30 days prior to randomization
Relapse occurred during the 60 days prior to randomization
Previous history of a malignancy other than basal cell carcinoma of the skin or carcinoma in situ that has been in remission for more than one year
Severely limited life expectancy by another co-morbid illness
Active or chronic severe infection.
History of previous diagnosis of myelodysplasia or previous hematologic disease or current clinically relevant abnormalities of white blood cell counts
Pregnancy or risk or pregnancy (this includes patients that are unwilling to practice active contraception during the duration of the study)
eGFR < 60 mL/min/1.73m2 or known renal failure or inability to undergo MRI examination.
Inability to give written informed consent in accordance with research ethics board guidelines

Sites / Locations

Karolinska Institute, Karolinska University Hospital Solna
Karolinska Institute, Karolinska University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open label single arm study

Arm Description

All patients will be treated with 1 single dose of IV infusion of autologous bone-marrow derived mesenchymal stem cells (1-2 million cells/kg body weight) and their therapeutic response will be followed over 48 weeks.

Outcomes

Primary Outcome Measures

To evaluate number of participants with an adverse event related to the treatment.

Adverse events is defined as any untoward or undesirable medical occurence in the form of signs, symptoms, abnormal findings or diseases that emerge during the study period, regardless of causal relationship to the study drug.

To evaluate effects on MS disease activity measured by cumulative number of MRI T2 lesions.

Brain MRI examination

Secondary Outcome Measures

To evaluate effects on MS disease activity measured by change in EDSS (expanded disability status scale).

EDSS assessed by neurologist.

To evaluate effect on peripheral blood immune cell populations.

Peripheral blood samples.

Full Information

NCT ID

NCT03778333

First Posted

January 14, 2015

Last Updated

May 30, 2023

Sponsor

Karolinska Institutet

1. Study Identification

Unique Protocol Identification Number

NCT03778333

Brief Title

Mesenchymal Stem Cells for Progressive Multiple Sclerosis_Sweden

Official Title

Mesenchymal Stem Cells for Progressive Multiple Sclerosis_Sweden

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

December 1, 2012 (Actual)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

December 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

To assess the safety of a single dose of IV infusion of bone-marrow derived autologous Mesenchymal Stem Cells (MSCs) in Multiple Sclerosis (MS) with progressive disease status.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autologous Mesenchymal Stem Cells, Multiple Sclerosis

Keywords

Mesenchymal Stem Cells, Multiple Sclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Model Description

Open-label phase 1, single-center, pre-post comparison study

Masking

None (Open Label)

Allocation

N/A

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Open label single arm study

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Autologous mesenchymal stem cells

Intervention Description

IV therapy with autologous bone-marrow derived mesenchymal stem cells

Primary Outcome Measure Information:

Title

To evaluate number of participants with an adverse event related to the treatment.

Description

Time Frame

48 weeks

Title

To evaluate effects on MS disease activity measured by cumulative number of MRI T2 lesions.

Description

Brain MRI examination

Time Frame

48 weeks

Secondary Outcome Measure Information:

Title

To evaluate effects on MS disease activity measured by change in EDSS (expanded disability status scale).

Description

EDSS assessed by neurologist.

Time Frame

48 weeks

Title

To evaluate effect on peripheral blood immune cell populations.

Description

Peripheral blood samples.

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of MS Active relapsing remitting MS (RRMS) as evidenced by presence of ≥ 1 clinically documented relapse in the past 12 months or ≥2 clinically documented relapses in the last 24 months. Secondary progressive MS with clinical progression as evidenced by an increase of 1 EDSS point (or 0,5 p if EDSS ≥ 5 at time for study start) in the last year or evidenced by ≥1 relapse or ≥ GEL at MRI performed within the last year. Primary progressive MS with clinical progression as evidenced by an increase of 1 EDSS point (or 0,5 p if EDSS ≥ 5 at time for study start) in the last year. Age_ 18-65 years Disease duration: 2-20 years EDSS 3,0-7,0 Exclusion Criteria: Subtype of MS not fulfilling inclusion criteria Treatment with any immunosuppressive therapy, including natalizumab and fingolimod, within the 3 months prior to randomization Treatment with interferon-beta or glatiramer acetate within the 30 days prior to randomization Treatment with corticosteroids within the 30 days prior to randomization Relapse occurred during the 60 days prior to randomization Previous history of a malignancy other than basal cell carcinoma of the skin or carcinoma in situ that has been in remission for more than one year Severely limited life expectancy by another co-morbid illness Active or chronic severe infection. History of previous diagnosis of myelodysplasia or previous hematologic disease or current clinically relevant abnormalities of white blood cell counts Pregnancy or risk or pregnancy (this includes patients that are unwilling to practice active contraception during the duration of the study) eGFR < 60 mL/min/1.73m2 or known renal failure or inability to undergo MRI examination. Inability to give written informed consent in accordance with research ethics board guidelines

Facility Information:

Facility Name

Karolinska Institute, Karolinska University Hospital Solna

City

Stockholm

ZIP/Postal Code

171 76

Country

Sweden

Facility Name

Karolinska Institute, Karolinska University Hospital

City

Stockholm

ZIP/Postal Code

17176

Country

Sweden

12. IPD Sharing Statement

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Mesenchymal Stem Cells for Progressive Multiple Sclerosis_Sweden

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